Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K222357
    Device Name
    DenMat Glutaraldehyde Desensitizer
    Date Cleared
    2022-08-09

    (5 days)

    Product Code
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    DenMat Holding, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    · To reduce pain in exposed cervical areas not requiring restoration. · To alleviate dentinal sensitivity after preparation of teeth to receive indirect or direct restorations.
    Device Description
    DenMat Glutaraldehyde Desensitizer is an aqueous, 5% glutaraldehyde-based desensitizer with 35% Hydroxy-ethyl Methacrylate (HEMA - a pre-primer resin) designed for use with 4th and 5th generation adhesives. DenMat Glutaraldehyde Desensitizer works by coagulating the plasma proteins contained within the dentinal tubule fluid. This coagulation forms an initial "plug" (which can be seen to a depth of 200 microns), eliminating the movement of fluid within the tubules-the root cause of dentinal sensitivity.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1